News & Analysis as of

Distributors Regulatory Requirements Food and Drug Administration (FDA)

Morgan Lewis - As Prescribed

Distribution Chain Compliance for Medical Devices

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more

Hogan Lovells

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to...

Hogan Lovells on

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more

Troutman Pepper Locke

Virginia Takes Action Against Retailer Selling THC Products

Troutman Pepper Locke on

On September 14, Virginia’s Attorney General (AG) Jason Miyares issued a letter to the registered agent of the Good Vibes Shop, a Radford, VA store, for selling tetrahydrocannabinol (THC) products without proper labeling and...more

Perkins Coie

FDA Publishes Draft Guidance For Submitting Cosmetic Product Facility Registrations and Product Listings Under MoCRA

Perkins Coie on

The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more

Dickinson Wright

[Webinar] The Regulatory Landscape for Cannabis Products in the U.S. and Canada - Is the Grass Greener on the Other Side? -...

Dickinson Wright on

The current regulation of cannabis products in the U.S. and Canada has left many dazed and confused. There seems to be a lot of confusion and misinformation on the regulation of these products on both sides of the border....more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

Mintz - Health Care Viewpoints

5 Key Reasons to Ensure Ongoing Compliance with State Distributor Licensing Requirements

Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an...more

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